Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Woman's
Study ID
NCT04047849
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Preterm Birth
  • Preterm Labor
  • Preterm PROM (Pregnancy)
  • Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture)
  • Rupture of Membranes; Premature
  • Rupture of Membranes; Premature, Affecting Fetus

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Antibiotics, oral Azithromycin and oral Amoxicillin — DRUG
    Azithromycin (500mg day one followed by 250mg per day for 4 more days) and amoxicillin (500mg orally three times daily for 7 days) for a total course of seven days of antibiotic therapy

Study Details

This study is a non-blinded, prospective, randomized controlled trial designed to compare the effect of outpatient oral antibiotics (i.e., amoxicillin and azithromycin) on the length of time (days) that pregnancy continues after a patient's water bag has ruptured prematurely. If a patient has been diagnosed with rupture of their water bag between 18 0/7 weeks and 22 6/7 weeks and there are no other associated complications with the pregnancy, the patient is eligible for initial consideration for this study. Patients will be admitted to the hospital for a 24-hour monitoring period. If the patient remains without further complications during this monitoring period, the patient will be eligible for enrollment. If enrollment is desired, the patient will be randomly assigned to receive either antibiotics (treatment arm of the study) or no antibiotics (control arm of the study). The treatment arm will receive an outpatient, 7-day course of oral antibiotics (azithromycin and amoxicillin) with the first dose given in the hospital to ensure no side effects. The control arm will not receive outpatient antibiotics. Both groups will have weekly, office follow-up visits with high-risk pregnancy specialists to ensure no further complications. Both groups will be admitted to the hospital if the patients reach 23 0/7 weeks without complications. At this time the patients will receive all medications and therapies recommended by the governing board of OBGYNs. Subjects of both groups will also be admitted before 23 0/7 weeks if further complications noted either at their clinic follow up visits or anytime outside of the hospital. The duration of time that the patient remains pregnant after breaking of the water bag will be compared in each group. The investigators will also see if there is a difference in the number of patients able to reach 23 0/7 weeks between each group (treatment versus control).

Key Dates

Start date
Aug 28, 2019
Status verified
Jan 2021
Primary completion
Jul 1, 2021
Completion
Jul 1, 2021

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Antibiotics
    This will include those subjects randomized into the treatment arm, receiving the outpatient antibiotic course of azithromycin and amoxicillin prior to re-admission at viability (23 0/7 weeks gestation). They will receive a single, 500mg dose of Azithromycin given prior to discharge to home, followed by 250mg daily for 4 more days, and Amoxicillin 500mg orally TID for 7 days (first dose also being given prior to discharge home).
  • No Intervention: No antibiotics
    This will include those subjects randomized into the control arm and will not receive outpatient antibiotics prior to re-admission at viability (23 0/7 weeks gestation).

Primary Outcome Measure

Latency period [ Time Frame: Patient will be monitored from the date of diagnosis of previable prelabor rupture of membranes until date of delivery. This could vary from a duration of less than 1 day to 112 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Woman's HospitalBaton RougeLouisiana70817
Ericka Seidemann
[email protected]
225-231-5296
Felicia V LeMoine, MD (SUB_INVESTIGATOR)
Robert C Moore, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baton Rouge, LA

By research site
Woman's Hospital· Baton Rouge, LA

Related Studies